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Phase II of High-dose Therapy in Elderly Patients With Relapsed Aggressive NHL or Resistant to First Line Therapy

NCT02371161 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 135

Last updated 2018-04-25

No results posted yet for this study

Summary

A phase II prospective, non-randomized study. The study aim is to evaluate the feasibility and activity of high-dose therapy with stem cell in elderly patients with aggressive lymphoma relapsed FIT or resistant to first line therapy.

Conditions

  • Non Hodgkin Lymphoma

Interventions

DRUG

R-DHAP/R-ICE

R-DHAP/R-ICE 3 cycles every 21 days: 1. R-DHAP * Rituximab 375 mg/m2, e.v. day 1 * Desamethasone 40 mg days 1-4 * cis-Platino100 mg/m2, day 2 (if ≥70 years 75 mg/m2) * Aracytin 2000 mg/m2, e.v. day 3 (if ≥70 years 1500 mg/m2) 2. R-ICE * Rituximab 375 mg/m2, e.v. day 1 * Etoposide 100 mg/mq, e.v. days 1,2,3 (if ≥70 years 75 mg/mq) * Ifosfamide with Mesna equidone 5000 mg/mq, day 2 (if ≥70 years 3750 mg/mq) * Carboplatino AUC=5, e.v. (max 800 mg/mq), day 2 (if ≥70 years AUC=4) Conditioning BEAM or FEAM

Sponsors & Collaborators

  • Fondazione Italiana Linfomi - ETS

    lead OTHER

Principal Investigators

  • Luca Castagna, MD · IRCCS Humanitas

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
65 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-02-28
Primary Completion
2018-12-31
Completion
2023-02-28

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02371161 on ClinicalTrials.gov